Liver Injury by Statins in Patients With History of Hepatitis B Virus Infection
- Conditions
- Hepatitis B Virus Infection HistoryLiver Injury
- Registration Number
- NCT02808299
- Brief Summary
The purpose of this study is to investigate the incidence of liver injury by statins in coronary heart disease (CHD) patients with history of hepatitis B virus (HBV) infection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 600
Inclusion Criteria
- patients with CHD receive long-term statin treatment
Exclusion Criteria
- ALT is over ULN at baseline
- infection of Hepatitis A Virus, Hepatitis C Virus or Hepatitis E Virus
- triglyceride is over 4.5 mmol/L
- decompensated liver cirrhosis (Child B or C)
- active stage of HBV
- infection of Burkitt's lymphoma virus or cytomegalovirus, or other acute infectious disease
- congestive heart failure
- malignant tumor
- autoimmune disease
- receive other potential hepatotoxicity drugs such as immunosuppressant, antituberculotic and non-steroid anti-inflammatory drug.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method changes of alanine transaminase (ALT, U/L) one month, three months, six months The peak increases of ALT from baseline to follow-up
number of participants with alanine transaminase (ALT) increasing over 3 folds of upper limit normally (ULN) one month, three months, six months
- Secondary Outcome Measures
Name Time Method number of participants with alanine transaminase (ALT) increasing over the ULN one month, three months, six months
Trial Locations
- Locations (1)
First Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
First Affiliated Hospital of Nanjing Medical University🇨🇳Nanjing, Jiangsu, China